En undersøgelse af baricitinib (LY3009104) hos børn med COVID-19 (COV-BARRIER-PEDS) (COV-BARRIER)
En multicenter, open-label, farmakokinetisk og sikkerhedsundersøgelse af baricitinib hos pædiatriske patienter fra 1 år til mindre end 18 år gamle indlagt med COVID-19
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Undersøgelse Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Studiesteder
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Campinas, Brasilien, 13060-080
- Instituto de Pesquisa Clínica de Campinas
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Campinas, Brasilien, 13034-685
- Centro de Pesquisa São Lucas
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Jaú, Brasilien, 17201130
- CECIP - Centro de Estudos do Interior Paulista
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Porto Alegre, Brasilien, 90410000
- Hospital de Clinicas de Porto Alegre
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Santo André, Brasilien, 09080-110
- Pesquisare Saúde
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Florida
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Orlando, Florida, Forenede Stater, 32806
- Arnold Palmer Hospital for Children
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Children's Hospital of Michigan
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Cleveland Medical Center
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Mexico City, Mexico, 04530
- Instituto Nacional de Pediatría
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Mexico City, Mexico, 06720
- Hospital Infantil de México Federico Gómez
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Pamplona, Spanien, 31009
- Complejo Hospitalario de Navarra
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Vitoria-Gasteiz, Spanien, 01009
- Hospital Universitario de Araba (HUA)- Hospital Txagorritxu
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Indlagt med coronavirus (SARS-CoV-2) infektion.
- Mandlige eller kvindelige deltagere fra 1 til <18 år.
- Kræver supplerende ilt og har brystbilleddiagnostiske fund for at bekræfte luftvejssygdom på grund af COVID-19 inden for 72 timer efter studiestart og tilmelding.
- Supplerende ilt inklusive, men ikke begrænset til: næsekanyle, maske, højflow-enheder, CPAP/BiPAP, invasiv mekanisk ventilation samt ECMO.
Ekskluderingskriterier:
- Modtager biologiske behandlinger (såsom Tumor Necrosis Factor [TNF]-hæmmere, interleukin-hæmmere, T-celle- eller B-celle-målrettede terapier, interferon eller Janus-kinase-hæmmere (JAK)); eller får andre immunsuppressive midler, således at deltagelse i undersøgelsen efter investigatorens mening ville sætte deltageren i en uacceptabel risiko for immunsuppression.
Bemærk: En udvaskningsperiode er påkrævet før screening.
- Modtager stærke hæmmere af Organic Anion Transporter 3 (OAT3) (såsom probenecid), som ikke kan afbrydes ved studiestart.
- Få diagnosen aktuel aktiv tuberkulose (TB) eller, hvis kendt, latent tuberkulose behandlet i mindre end 4 uger med passende anti-tuberkuloseterapi i henhold til lokale retningslinjer (kun efter historie, ingen screeningstest påkrævet).
- Mistanke om alvorlig, aktiv bakteriel, svampe-, viral eller anden infektion (udover COVID-19), som efter investigators mening kan udgøre en risiko ved indtagelse af forsøgsprodukt.
- Har modtaget en levende vaccine inden for 4 uger før screening, eller har til hensigt at modtage en levende vaccine under undersøgelsen. Bemærk: Brug af ikke-levende (inaktiverede) vaccinationer er tilladt for alle deltagere.
- Kræv invasiv mekanisk ventilation, inklusive ekstrakorporal membraniltning (ECMO) ved studiestart.
- Aktuel diagnose af aktiv malignitet, der efter investigators mening kan udgøre en risiko ved indtagelse af forsøgsprodukt.
- Har en historie med venøs tromboemboli (VTE) (dyb venetrombose [DVT] og/eller lungeemboli [PE]) eller anses for høj risiko for VTE (DVT/PE).
- Forventet udskrivning fra hospitalet eller overførsel til et andet hospital (eller en anden enhed), som ikke er et studiested inden for 72 timer efter studiestart.
- Har neutropeni (absolut neutrofiltal <1000 celler/mikroliter).
- Har lymfopeni (absolut lymfocyttal <200 celler/mikroliter).
- Har alaninaminotransferase (ALT) eller aspartataminotransferase (AST) >5 gange AAULN.
- Estimeret glomerulær filtrationshastighed (eGFR) (Modification of Diet in Renal Disease [MDRD]) <40 milliliter/minut/1,73 kvadratmeter.
- Har en kendt overfølsomhed over for baricitinib eller et eller flere af dets hjælpestoffer.
- Er i øjeblikket tilmeldt ethvert andet klinisk studie, der involverer et undersøgelsesprodukt eller enhver anden form for medicinsk forskning, der vurderes ikke at være videnskabeligt eller medicinsk forenelig med denne undersøgelse. Bemærk: Deltageren bør ikke tilmeldes (startes) i et andet klinisk forsøg til behandling af COVID-19 eller SARS CoV-2 til og med dag 28.
- Er gravid, eller agter at blive gravid eller amme under undersøgelsen.
- Er, efter investigator eller sponsor, i risiko for immunsuppression eller på anden måde uegnet til at indgå i undersøgelsen.
- Bruger eller vil bruge en ekstrakorporal blodrensningsanordning (EBP) til at fjerne proinflammatoriske cytokiner fra blodet, såsom en cytokinabsorptions- eller filtreringsanordning, for eksempel CytoSorb®.
- Er det, efter investigators opfattelse, usandsynligt, at de overlever i mindst 48 timer efter screening.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Baricitinib QD
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Gives mundtligt
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib
Tidsramme: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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PK: Overall AUC of Baricitinib in pediatric participants with COVID-19.
Summarized data were reported in this outcome measure.
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Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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PK: Maximum Concentration (Cmax) of Baricitinib
Tidsramme: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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PK: Overall Cmax of Baricitinib in pediatric participants with COVID-19.
Summarized data were reported in this outcome measure.
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Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants Who Progressed to Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) by Day 28
Tidsramme: Day 1 to Day 28
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NIAID-OS is an assessment of clinical status. The scale is as follows: 1)Not hospitalized, no limitations on activities; 2)Not hospitalized, limitation on activities and/or requiring home oxygen; 3)Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4)Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5)Hospitalized, requiring supplemental oxygen; 6)Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7)Hospitalized, on invasive mechanical ventilation or ECMO; 8)Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Progression to ventilation (only progressed excluding death) by Day 28 was defined as reaching NIAID-OS ≥6; for participants with baseline NIAID-OS 6, progression required NIAID-OS ≥7, and those with a baseline score of 7 were excluded. |
Day 1 to Day 28
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Percentage of Participants Who Died or Progressed to Non-Invasive Ventilation/High-Flow Oxygen, Invasive Mechanical Ventilation, or ECMO by Day 28
Tidsramme: Day 1 to Day 28
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NIAID-OS is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Progression to ventilation (who died or progressed) by Day 28, defined as reaching a score ≥6; for baseline scores of 6 and 7, progression required scores ≥7 and Death (NIAID-OS=8). |
Day 1 to Day 28
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Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital
Tidsramme: Day 4, Day 7, Day 10, Day 14, and Day 28
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NIAID-OS is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. At each visit (Day 4/7/10/14/28), percentage of participants with ≥1-point improvement on NIAID-OS or discharged alive by that visit were reported in this outcome measure. |
Day 4, Day 7, Day 10, Day 14, and Day 28
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Number of Ventilator-Free Days (Days Free of Invasive Mechanical Ventilation)
Tidsramme: Day 1 to Day 28
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NIAID-OS is an assessment of clinical status. The 8-point scale as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Number of ventilator free-days were defined as total number of days participants were alive and had NIAID-OS <7 point (free of invasive mechanical ventilation/ECMO) by Day 28. |
Day 1 to Day 28
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Time to Recovery
Tidsramme: Day 1 to Day 28
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NIAID-OS is an assessment of clinical status. The 8-point scale as follows:1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Time to recovery was time from Day 1 to the first day the participant's maximum daily NIAID-OS was 1, 2, or 3. Participants who died before recovery were censored at Day 28 (not considered recovered). |
Day 1 to Day 28
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Tidsramme: Day 4
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NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 4 score. A higher positive value indicates greater improvement. |
Day 4
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Tidsramme: Day 7
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NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 7 score. A higher positive value indicates greater improvement. |
Day 7
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Tidsramme: Day 10
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NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 10 score. A higher positive value indicates greater improvement. |
Day 10
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Tidsramme: Day 14
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NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 14 score. A higher positive value indicates greater improvement. |
Day 14
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Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28
Tidsramme: Day 28
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NIAID-OS is an assessment of clinical status. The 8-point scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range: 1-8); minimum value: 1 (not hospitalized, no limitations on activities); maximum value: 8 (death); higher scores indicate worse clinical status. Improvement was defined as the reduction from baseline in the NIAID-OS score, calculated as baseline score minus Day 28 score. A higher positive value indicates greater improvement. |
Day 28
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Duration of Hospitalization
Tidsramme: Day 1 to Day 28
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NIAID-OS is an assessment of clinical status. The 8-point scale as follows:1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen- no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care; 5)Hospitalized, requiring supplemental oxygen; 6)Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7)Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. NIAID-OS (range:1-8); minimum value:1; maximum value:8; higher scores indicate worse clinical status. Duration of hospitalization through Day 28 was defined as the total number of days with NIAID-OS scores of 4, 5, 6, or 7. Participants who died on or before Day 28 were assigned 28 days. For Day 1, hospitalization status was determined using worst NIAID-OS value recorded between baseline and the remainder of Day 1. |
Day 1 to Day 28
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All-Cause Mortality
Tidsramme: Baseline (Day 1) up to end of follow-up (up to Day 60)
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Number of deaths by day 60 were reported in this outcome measure.
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Baseline (Day 1) up to end of follow-up (up to Day 60)
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Duration of Stay in the Intensive Care Unit (ICU) in Days
Tidsramme: Day 1 to Day 28
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Duration of ICU stay through Day 28 was defined as the total number of days spent in the ICU through Day 28, with days following death counted up to Day 28.
For participants alive at Day 28, duration was calculated as (Date of ICU discharge - Date of ICU admission) + 1.
For participants who died in the ICU on or before Day 28, duration was calculated as (Date of death - Date of ICU admission + 1) + (Date of Day 28 - Date of death).
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Day 1 to Day 28
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 18253
- I4V-MC-KHAB (Anden identifikator: Eli Lilly and Company)
- 2021-001338-21 (EudraCT nummer)
- 2024-516824-32-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .